Infectious Disease

FDA authorizes Novavax’s COVID-19 vaccine, expanding options in US

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Califf and Marks report no relevant financial disclosures.

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The FDA issued an emergency use authorization for Novavax’s two-dose COVID-19 vaccine, making it the fourth COVID-19 vaccine available for use in the United States.

The FDA said the vaccine “has met the statutory criteria” for an emergency use authorization (EUA) for people aged 18 years or older and that data show the benefits of the vaccine outweigh its risks.

Novavax vaccine efficacy against mild, moderate or severe COVID-19 was 90.4% among adults and 78.6% among people aged 65 years or older.

FDA.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Robert M. Califf, MD, said in a press release .

The EUA came more than a month after the FDA’s vaccine advisory committee voted to recommend the vaccine, and almost 6 months after Novavax submitted its EUA request.

Experts have expressed hope that people hesitant to receive one of the other COVID-19 vaccines may be more open to Novavax’s protein-based vaccine, which is given in two doses 3 weeks apart. It contains a SARS-CoV-2 spike protein produced from insect cells and an adjuvant that contains extracts from the bark of a tree native to Chile.

The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled trial in the US and Mexico among people aged 18 years or older with no evidence of a past SARS-CoV-2 infection through 6 days after receiving the second vaccine dose.

Approximately 17,200 participants received the vaccine and around 8,300 received a placebo. Overall, researchers calculated the vaccine’s efficacy to be 90.4% in preventing mild, moderate or severe COVID-19, with 17 cases of COVID-19 occurring in the vaccine group and 79 in the placebo group. It was 78.6% effective in a subset of people aged 65 years or older.

The safety of the vaccine was assessed in a clinical trial that included more than 50,000 participants — approximately 26,000 who received the vaccine and 25,000 who received placebo. Nearly 21,000 vaccine recipients had at least 2 months of safety follow-up after their second dose, with data shared by the FDA showing that the most commonly reported side effects included pain/tenderness, redness and swelling at the injection site; fatigue muscle pain; headache joint pain; nausea/vomiting; and fever.

“The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDA’s rigorous and comprehensive scientific and regulatory review,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release.

For now, the FDA expects Novavax to continue clinical trials to obtain additional safety and effectiveness data and pursue approval.

Novavax reported in February that the vaccine was 79.5% effective against mild, moderate or severe COVID-19 among adolescents aged 12 to 17 years. Data from the pediatric trial were not mentioned in the FDA’s authorization.

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